Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are:

Use of personal CLC system for 2 weeks
Use of personal CLC system and adding a behavioral adaptation module (BAM) for 4 weeks
Use of personal CLC system and adding the ABC which includes: BAM and PAM (which includes ATM and WST described below) for 16 weeks.

The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay ‘what if’ scenarios for the participant based on various combinations of insulin pump parameter changes.

Source: View full study details on ClinicalTrials.gov

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December 7, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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